and finding enduring solutions

January 11, 2019

The Honorable Scott Gottlieb, M.D.

Commissioner

Food and Drug Administration

Attention: Dockets Management Staff (HFA-305), FDA-2018-N-3272

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Submitted electronically to: http://www.regulations.gov

Re: FDA-2018-N-3272, Identifying the Root Causes of Drug Shortages and Finding Enduring

Solutions; Public Meeting; Request for Comments

Dear Commissioner Gottlieb,

The Premier healthcare alliance appreciates the opportunity to submit comments to the Food and Drug

Administration (FDA) on the request for comments titled “Identifying the Root Causes of Drug Shortages

and Finding Enduring Solutions” which was published in the September 10, 2018 Federal Register. In the

request for comments, the FDA seeks input on the underlying systemic causes of drug shortages and

recommendations for actions to prevent or mitigate drug shortages.

Premier is a leading healthcare improvement company, uniting an alliance of more than 4,000 U.S.

hospitals and health systems and approximately 165,000 other providers and organizations to transform

healthcare. With integrated data and analytics, collaboratives, supply chain solutions, consulting and other

services, Premier enables better care and outcomes at a lower cost. A 2006 Malcolm Baldrige National

Quality Award recipient, Premier plays a critical role in the rapidly evolving healthcare industry, collaborating

with members to co-develop long-term innovations that reinvent and improve the way care is delivered to

patients nationwide. A key component of our alliance is our Integrated Pharmacy Program, which combines

essential clinical data with purchasing power to deliver reduced costs, improved quality and safety, and

increased knowledge-sharing with other healthcare professionals.

Premier has been a leader in addressing drug shortages for over twenty years and is committed to

eliminating drug shortages. Premier believes that a holistic, multi-stakeholder, and inter-agency

approach is necessary to truly address drug shortages. Premier applauds the FDA for its efforts to date to

mitigate drug shortages, but drug shortages continue to persist and more needs to be done, including

legislative and regulatory action, to eliminate drug shortages. Sustainable solutions to address drug

shortages must decrease barriers to entry, namely the time and cost to enter the marketplace, while

maintaining the quality and safety of the product.

http://www.regulations.gov/

Dr. Scott Gottlieb January 11, 2019 of 14

I. Premier is a Leader in Eliminating Drug Shortages to Prevent Disruption to Patient Care

Over the past twenty years, Premier has been a leader in addressing drug shortages to minimize the

downstream impact to health systems and patient care. Premier’s multifaceted and ongoing initiatives to

mitigate drug shortages include, but are not limited to:

• Member Resources – Premier maintains a drug shortage website for our members that is updated

in real-time and is intended to serve as a “one stop shop” for our members by collating shortage

information from both the FDA and American Society of Health System Pharmacists (ASHP). The

website also provides information and educational materials about therapeutic alternatives,

pertinent updates to clinical guidelines, and best practices for handling shortages. Premier also

employs a dedicated team of pharmacists that serve as a resource for members during drug

shortages, including assisting members with identifying alternative medication therapies. Finally,

Premier has a weekly pharmacy newsletter for members that highlights information about

shortages.

• Failure to Supply Clauses - Premier includes failure to supply (FTS) clauses in manufacturer

contracts to help health systems recoup increased expenditures as a result of purchasing alternate

medications at a higher cost during a drug shortage. Historically, FTS clauses have been difficult

to enforce as the process to calculate increased expenditures and file claims with manufacturers

was manual, complicated, and resource intensive. In 2009, Premier established an automated

mechanism to help optimize recovery for drug shortage costs. Using Premier’s extensive data

capabilities, Premier can determine when an item is not shipped to a member due to a shortage

and submits an FTS claim on behalf of the health system to the manufacturer. Premier’s FTS

program has helped members recoup over $70 million of increased expenditures associated with

drug shortages since its inception.

• PremierProRx – For the past eight years, Premier has invested in the PremierProRx program that

focuses primarily on sterile injectable products and has 91 National Drug Codes (NDCs) that are

currently on the drug shortage list. The PremierProRx program delivers additional value and

savings to members by creating stability in the marketplace for both supply and pricing through

long-term contracts. Manufacturers for the PremierProRx program are carefully selected based on

their record of quality and history of compliance with all regulatory and FDA standards. The

PremierProRx program has also contracted directly with active pharmaceutical ingredient (API)

manufacturers, for example in the case of cephalosporin, to combat situations where a shortage

of API resulted in a downstream drug shortage.

• Data Mining – In certain situations, Premier can utilize its robust data capabilities to predict future

shortages and alert the FDA and ASHP, as well as proactively implement drug shortage mitigation

strategies for its members. Premier also leverages its robust data capabilities to share data, for

example most recently with the injectable opioid shortage, with agencies such as the FDA, Drug

Enforcement Administration (DEA), Centers for Medicare and Medicaid Services (CMS), and

others to underscore the duration and severity of shortages.

• Interim Solutions - To help temporarily combat drug shortages while a longer-term strategy is

being developed, Premier maintains a network of 503B outsourcing facilities to compound

products using current good manufacturing practices (cGMP). Given Premier’s commitment to

quality and safety, Premier personally inspects every 503B outsourcing facility using a 48-page


long assessment tool that goes above and beyond FDA and state board of pharmacy

requirements.

• Manufacturer Relationships – A tenet of Premier’s strategy to end drug shortages for our

members is our positive and long-standing relationships with manufacturers. Premier is able to

discuss shortages directly with manufacturers and understand the root cause behind the shortage

as well as the manufacturer’s remediation strategy. Manufacturers tend to be very transparent with

Premier as a trusted partner and forthcoming about Title X reporting requirements, sometimes in

advance of formally reporting to the FDA.

• Allocation – In shortage situations, Premier utilizes a dynamic allocation process to help ensure

member access to an adequate supply of product based upon prior utilization. The allocation

process helps to prevent hoarding and helps maintain a health supply chain for as long as possible

while pursuing additional mitigation strategies.

• ProvideGx – To build upon Premier’s eight-year track record of direct contracting for healthcare

supplies and the PremierProRx program that is successfully providing uninterrupted access to

more than 91 shortage NDCs, Premier has established a new subsidiary company to supply

shortage drugs. The goal of the new company, ProvideGx, is to permanently address the drug

shortage problem, ensuring continuous access to life-saving products at an affordable price.

ProvideGx will also target and supply medications that lack market competition and are at risk for

shortages and price spikes.

ProvideGx provides a vehicle for Premier to invest in innovative new business models and

partnerships to address drug shortages, including partnering with quality generic drug

manufacturers that can supply shortage products, co-funding the development of affordable

products that address specific market needs, securing contracts for active pharmaceutical

ingredients to ensure a continuous supply, as well as strategic sourcing agreements. ProvideGx

has already partnered with five high-quality generic manufacturers to address a targeted pipeline

of 60 crucial drugs, and expects to launch its first product next month, pending approval by the

U.S. Food and Drug Administration.

ProvideGx is guided by an advisory council of 15 member health systems to help prioritize our

efforts based on the need of providers on the front-lines of patient care that are most impacted by

drug shortages.

• Advocacy - Premier has been, and will continue to be, an active voice in advocating for legislative

and regulatory changes to help combat drug shortages. Recent examples of Premier’s leadership

in this area include:

o Competitive Generic Therapy (CGT) Pathway – Premier was a major proponent of the

CGT pathway and advocated for its inclusion in the Food and Drug Administration

Reauthorization Act (FDARA)1 legislation. Premier applauds the FDA for expeditiously

implementing the pathway and approving the first product under the pathway in

September of 2018.

1 Pub.L. 115-52


o Injectable Opioid Shortages – During the recent (and ongoing) injectable opioid shortage,

Premier was able to proactively identify that a major shortage was about to occur and alert

the FDA and ASHP. In addition, Premier worked tirelessly to identify alternate and able

manufacturers of the products and provide monthly data to the DEA to demonstrate the

severity of the shortage. However, communication with the DEA hit a roadblock as the

DEA was unwilling to reallocate quota to able manufacturers. Premier was able to apply

congressional pressure to the DEA that ultimately resulted in the DEA agreeing to

reallocate quota to able manufacturers. To date, the severity of the shortage has eased,

although it is still a major shortage impacting providers.

o FDASIA Title X – Premier was a major proponent of the drug shortage notification

requirements and advocated for their inclusion in the Food and Drug Administration Safety

and Innovation Act (FDASIA)2 legislation. Premier believes these provisions have been

impactful but can be strengthened to increase their impact in mitigating shortages.

While Premier has made significant progress in reducing the impact of drug shortages for our members,

we have not been able to eliminate them. More needs to be done and Premier is continuing to grow and

evolve our drug shortage strategy to eliminate drug shortages once and for all.

II. Root Causes of Drug Shortages Are Multifactorial and Solutions Must be Attainable,

Practical, and Sustainable

Premier has worked extensively with its members to identify the root causes of drug shortages and develop

sustainable solutions to address them. Given that there is no single cause of drug shortages and often

multiple contributing factors lead to a drug shortage, there is also no single solution to address

drug shortages. The FDA will need to implement multiple solutions targeting the various causes of drug

shortages to truly address the situation and eliminate drug shortages. The following outlines several root

causes of drug shortages that Premier has identified including examples of each as well as sustainable

solutions to address each root cause. Many of the sustainable solutions can be implemented immediately

under the FDA’s current authority, while others may require legislative or regulatory action, as well as inter-

agency collaboration, to implement.

• Entry of a Low Cost Competitor – In recent years, the entry of a low cost competitor to the

marketplace has resulted in a ripple effect disrupting the supply chain ultimately resulting in a drug

shortage. The following exhibits demonstrate two common examples of how the entry of a low cost

competitor has resulted in a drug shortage.

2 Pub.L. 112–144


Exhibit A: Entry of a low cost competitor results in others exiting the market

Exhibit B - Reentry of a low cost competitor results in others exiting the market and hesitant to

help mitigate future shortages

Solutions to address the ripple effect caused by the entry of a low cost competitor hinge on the

need to decrease barriers to entry, namely the time and cost to enter the marketplace, while

maintaining the quality and safety of the product. Specifically:

o Improve regulatory efficiency during drug shortages: During a drug shortage, a key

factor in determining the duration and severity of the shortage is how soon an alternate

manufacturer can enter the marketplace to help alleviate the shortage. The FDA plays a

key role in advancing abbreviated new drug applications (ANDAs) through the process,

and there are opportunities for the FDA to improve regulatory efficiency during drug


shortages to help decrease manufacturer burden and increase predictability. Specific

examples include:

▪ Expedite review of newly submitted ANDAs by beginning review of the

application while awaiting submission of the 6-month stability data. A parallel

review process can decrease the amount of time needed to review an ANDA and

therefore help bring a competitor to market sooner.

▪ Expedite facility inspections and review of manufacturing changes that would

help mitigate or prevent a drug shortage.

▪ Appoint a senior-level drug shortage navigator to coordinate with each

manufacturer who submits an ANDA for a drug shortage product. This position

should reside within the Office of Generic Drugs (OGD) and responsibilities would

include shepherding drug applications through the internal review and approval

processes at FDA and maintaining communication with the manufacturer. The

senior-level drug shortage navigator should also have the authority to request

expedited review of ANDAs or inspections of facilities to help prevent or mitigate a

drug shortage.

▪ Expedite new drug applications (NDAs) for shortage drugs in situations

where a NDA is preferred over an ANDA to help improve the formulation, dosage

form, delivery system, or safety of a shortage drug.

o Create incentives for manufacturers to enter the market for low revenue products:

▪ Develop a mechanism for reimbursing generic drug user fee act (GDUFA)

fees to manufacturers who submitted an ANDA for a shortage drug after a

specified period of successfully entering the market. The increased GDUFA

fees, and newly created program fees for generic manufacturers, are often a

barrier to entry as the potential revenue on a shortage drug does not outweigh the

cost of filing fees. A reimbursement mechanism, in lieu of waiving or reducing fees

upfront, will help ensure market entry and provide incentive for manufacturers to

ensure a quality manufacturing process. A reimbursement mechanism will also

help deter manufacturers from purposely waiting until a drug is in shortage to file

an ANDA in order to take advantage of a waived or reduced GDUFA fee.

▪ Address the loophole in the Competitive Generics Therapy (CGT) pathway

so that the first approved manufacturer is guaranteed exclusivity. Currently,

the first manufacturer is only granted exclusivity if it begins marketing the product

before the FDA approves a second manufacturer, something that can occur days

after the first approval. A manufacturer needs affirmation that as the first

manufacturer it will have a period of exclusivity and enough time to bring its product

to market upon approval.


o Create pathways for interim solutions to help address drug shortages:

▪ Expand the FDA drug shortage list to include regional shortages and shortages

based upon dosage or administration form, similar to the criteria used for the ASHP

drug shortage list. A more comprehensive list will allow the temporary use of 503B

outsourcing facilities to mitigate shortages while a longer-term and more

permanent strategy is being developed.

• Quality and Manufacturing Issues - In a market with few manufacturers, when one manufacturer

encounters quality or manufacturing issues and exits the market for an extended period,

downstream pressure is placed on the remaining manufacturers to ramp up supply and fill the

market void. In certain scenarios, external factors prevent other manufacturers from ramping up

such as capacity restrictions and DEA quota allocations, resulting in drug shortages.

As depicted in the following exhibit, a nationwide acute shortage of several injectable opioids that

are critical for patient care occurred at the end of 2017 due to a single manufacturer encountering

quality and manufacturing issues at several of their plants. The issue was further compounded by

a lack of immediate coordination between the FDA and DEA to release additional quota to

manufacturers who were able and willing to ramp up production to help mitigate the impact of the

shortage.

Exhibit C - The ongoing shortage of injectable narcotics has been a major patient safety concern

for health systems

Solutions to address quality and manufacturing issues include:

o Improve the regulatory violation process for cGMP by shortening turnaround times

and improving and standardizing processes for FDA reviews to identify problems prior to

shutting down facilities. More rapid review of corrective actions taken by manufacturers

would help moderate fluctuations.


o Improve coordination within various FDA offices - such as ORA, ODS, OGD – to

understand downstream impact of cGMP violations or manufacturer shutdowns on drug

shortages and proactively develop mitigation strategies.

o Develop a list of critical medications that are needed for patient care in case of an

emergency, natural disaster, or other urgent situation. Require manufacturers of critical

medications to report where such medications are manufactured so the FDA can use

mapping technology to account for potential impact of natural disasters, facility shutdowns,

and other situations on drug shortages and appropriately mitigate.

o Appoint an inter-agency, White House-level ‘Drug Shortage Point Person’ to improve

cross-agency coordination on issues related to drug shortages, such as the ongoing

shortage of generic injectable opioids. A Drug Shortage Point Person will streamline

needed communication and cooperation among stakeholders such as the HHS, DEA,

FEMA, VA, CMS, FDA, DOD and other stakeholders.

• API or Raw Materials Shortages - Over 80 percent of API and raw materials required for drug

manufacturing are manufactured overseas.3 The heavy reliance on foreign manufacturing of API

and raw materials results in downstream drug shortages when a foreign manufacturer fails to meet

cGMP or exits the market. In addition, the extent and duration of API or raw material shortages is

unknown and results in downstream impact on hoarding and the gray market. Furthermore, the

Chinese Blue Sky Initiative is resulting in API and raw material manufacturers being required to

either halt production or shut down resulting in concerns that this may further exacerbate shortages,

and may result in increased shortages for oral solid dosage forms. Finally, new tariffs are also

putting pressure on foreign manufacturers of raw materials and may lead to entities exiting the

market resulting in downstream drug shortages.

For example, the recent valsartan recall was due to an impurity with the API and almost all

manufacturers relied on a single API manufacturer, resulting in a major shortage. In addition, the

recent injectable opioid shortages were exacerbated by an inability of the manufacturer to acquire

the raw materials necessary for the injector.

Solutions to address API or raw material shortages include:

o Create incentives to encourage on-shore manufacturing of API and raw materials.

o Extend FDASIA Title X reporting requirements to API and raw material

manufacturers, including strengthening the reporting requirements to include disclosure

of the problem resulting in the shortage, the extent of the shortage, and the expected

duration of the shortage to help understand the downstream impact on drug shortages.

o Prioritize FDA reinspection of facilities that are sole manufacturers of API or raw

materials when cGMP or other quality issues are identified. Develop action plans and work

closely with manufacturers to prevent facility shutdown and downstream drug shortages.

3 Source: http://www.consumerreports.org/cro/news/2014/04/are-generic-drugs-made-in-india-safe/index.htm


o Maintain a directory of API sources used by manufacturers to expedite downstream

notification and recall procedures if there is an issue with an API manufacturer and

implementation of drug shortage mitigation strategies.

• Change in API Requirements - Updates to United States Pharmacopeia (USP) monographs will

often result in changes to API requirements. The changes to API requirements are typically

effective immediately, resulting in shortages as manufacturers must suspend manufacturing using

the old API and await new API, which can take several months, to resume manufacturing.

For example, as depicted in the following exhibit, changes to the USP monograph for potassium

chloride resulted in an immediate shortage that lasted approximately six months until the new API

was available and manufacturers could begin production of finished dosage forms again.

Exhibit D - Changes to API requirements for potassium chloride resulted in a shortage

Solutions to address changes in API requirements include:

o Permit a phase-in period of at least 6-12 months for changes in API requirements where

old API can continue to be used until new API is available. An exception should exist if the

prior API was associated with harm or adverse events necessitating the need for a change

in API requirements.

• DESI Drugs - Drug Efficacy Study Implementation (DESI) drugs are often at-risk for shortages as

legacy manufacturers are required to exit the marketplace abruptly and typically only one or two

manufacturers reenter the marketplace under the new requirements. During a DESI drug shortage,

it is difficult for new manufacturers to enter the marketplace given the need to prove efficacy, an

expensive and timely process for manufacturers, often resulting in significant price increases to

offset the cost of entering the marketplace.

For example, as depicted in the following exhibit, potassium chloride experienced a significant

increase in price due to the DESI drug pathway. In addition, it created a sole source situation that

placed the drug at great risk for shortage.


Exhibit E – Potassium chloride experienced price spikes as a result of the DESI drug pathway

Solutions to address the DESI drug pathway include:

o Refine the “unapproved drugs” compliance policy initiative to permit the use of real-world

evidence to demonstrate efficacy.

o Announce in the Federal Register the first NDA submission for a DESI drug and solicit

additional NDA submissions. Allow for 18 to 24 months after the Federal Register notice

before requiring current manufactures to exit the market. This would help provide stability

in the market, mitigate threats of a shortage, and allow enough time for other manufacturers

to consider submitting a competing NDA.

o Lower, or remove altogether, NDA filing fees for DESI drugs to encourage

manufacturers to enter the market as high NDA fees are often a deterrent, or not feasible,

for generic manufacturers.

o Streamline and simplify filing requirements for DESI drugs, making the application

more akin to an ANDA, or at most a 505(b)(2) paper NDA. Generic manufacturers are often

not familiar with the NDA process and would be more inclined to submit applications if they

resembled a traditional ANDA.

o Expedite review of competing NDAs to encourage competition in the marketplace and

mitigate potential shortages due to reliance on a single manufacturer.

• Gray Market - During drug shortages, shortage drugs are often sold at exorbitant prices by

unauthorized vendors. The gray market creates patient safety concerns as the products may not

have been stored properly and therefore the integrity of the product cannot be confirmed. Recently,

several PremierProRx products have been found in the gray market with significant price increases:

o Ondansetron - 1642% price increase

o Naropin – 291% price increase

o Rocuronium – 691% price increase


Solutions to address the gray market include:

o Timely implementation of the Drug Quality and Security Act (DQSA) track and trace

requirements.

o Require distributors to implement checks and balances systems for shortage drugs,

similar to suspicious order monitoring requirements for controlled substances, to identify

potential diversion of shortage drugs to the gray market.

o Promote the reporting of gray market offers to the FDA Office of Criminal

Investigations and share reported incidents with the Federal Trade Commission (FTC).

o Implementation of CMPs for entities selling products to the gray market.

• Hoarding - During drug shortages, hoarding often occurs as providers are concerned about having

adequate supply of products and do not know the duration and severity of the shortage. This further

exacerbates shortages as product is not available in the supply chain for other entities and often

results in product being returned as unused or expired in lieu of being used for patient care.

Solutions to address hoarding include:

o Strengthen FDASIA Title X reporting requirements to include disclosure of the problem

resulting in the shortage, the extent of the shortage, and the expected duration of the

shortage to help alleviate provider concerns and discourage hoarding.

o Collate and make publicly available information about the severity of the shortage,

expected duration, and mitigation strategies (e.g. remediation efforts by manufacturer,

entry of additional manufacturers, potential importation, etc.). This information should be

provided in a uniform manner, be easily found on the FDA website, and updated in a timely

and consistent manner (e.g. monthly).

III. Robust Research Is Needed to Quantify the Clinical and Economic Impact of Drug Shortages

There is little research documenting the clinical and economic impact that drug shortages have on patient

outcomes and healthcare expenditures. One of the only studies to date that looked at the total cost of care

and patient impact of drug shortages utilized the Premier Healthcare Database (PHD) and found that the

2011 shortage of norepinephrine was significantly associated with increased mortality among patients with

septic shock.4 Understanding the clinical and economic impact of drug shortages is integral to

understanding the true impact of shortages and also deciphering what appropriate incentives or offsets

should be to help eliminate shortages. Therefore, funding should be allocated to study the clinical and

economic impact of drug shortages on patient outcomes and healthcare expenditures. Research

should be multi-faceted and encompass retrospective, prospective, quantitative, and qualitative studies.

4 Vail, Emily, Gershengorn, Hayley, Hua, May, Walkey, Allan, Rubenfeld, Gordon & Wunsch, Hannah. (2017). Association Between US Norepinephrine Shortage and Mortality Among Patients With Septic Shock. JAMA. 317.DOI: 10.1001/jama.2017.2841


The Premier Healthcare Database (PHD) is one of the most comprehensive electronic healthcare

databases containing robust data on more than 108 million inpatient admissions and 765 million outpatient

encounters for over 208 million unique patients. The PHD has been leveraged by hospitals, health systems,

academia, pharmaceutical manufacturers, CDC, CMS, NIH, and others to use real-world data to conduct

evidence-based and population-based analyses of drugs, devices, other treatments, disease states,

epidemiology, resource utilization, healthcare economics and clinical outcomes. Premier welcomes the

opportunity to discuss how the Premier Healthcare Database and its dedicated staff of skilled

professionals trained in medicine, pharmacy, epidemiology, public health, economics and statistics

can partner with the FDA to support studying the clinical and economic impact of drug shortages.

IV. A List of Critical Drugs Should be Developed Through a Consensus Development Process

Spearheaded by a Private Entity

As previously discussed, a list of critical medications should be developed that are needed for patient

care in case of an emergency, natural disaster, or other urgent situation. Medications on the critical drug

list would be subject to additional reporting requirements by manufacturers regarding exactly where these

medications are manufactured so the FDA can use mapping technology to account for potential impact of

natural disasters, facility shutdowns, and other situations impacting drug shortages and appropriately

mitigate.

In lieu of FDA creating the list of critical drugs, Premier recommends FDA endorse a neutral third-party

to work collaboratively with stakeholders representing pharmacy, providers, manufacturers,

patients, and others to develop the list of critical drugs using a consensus-based process. Having

a broad spectrum of representation and a neutral third-party lead the consensus development process will

allow those on the front lines of patient care to directly impact the list of critical medications. In addition,

having a neutral third-party serve as the convener will also allow for frequent updates to the list of critical

medications as needed and avoid differences between a FDA developed list and a privately developed list,

such as the case with FDA vs ASHP drug shortage lists.

To help begin the process, Premier’s National Pharmacy Committee and Pharmacy Affairs Subcommittee

reviewed work to date on the development of a critical drug lists by comparing and cross-referencing work

from the Healthcare and Public Health Sector Coordinating Council, World Health Organization List of

Essential Medications, Advanced Cardiac Life Support (ACLS), Pediatric Advanced Life Support (PALS),

CDC National Strategic Stockpile, and others. The following exhibit is a preliminary list of critical drugs

as recommended by Premier for further consideration and refinement.

Exhibit F – Draft List of Critical Medications

Emergent Situation/Class Critical Drugs

Anesthetics Local, Inhaled, Propofol

Pre-operative/sedative Midazolam, lorazepam, emergency syringes, morphine, hydromorphone, fentanyl

Palliative care Haloperidol, metoclopramide, ondansetron

Anaphylaxis/allergy Diphenhydramine, methylprednisolone, hydrocortisone, inhaled bronchodilators

Antidotes Expert Consensus Guidelines for Stocking of Antidotes in Hospitals That Provide Emergency Care


• https://www.annemergmed.com/article/S0196-0644(17)30657-1/fulltext

ACLS/PALS https://acls-algorithms.com/acls-drugs/

Anticonvulsants Midazolam, diazepam, lorazepam, phenytoin, VPA, phenobarb, mag sulfate

Anti-infectives Vancomycin, zosyn, cefazolin, doxy, bactrim refer to critical care guidelines for drugs to be administered within an hour of sepsis

Anti-tuberculosis Rifampin, INH

Anti-fungal Fluconazole

Anti-influenza Oseltamivir

Oncology Sole therapy, single source generics

Anti-anemia Multivitamin, folic acid

Antithrombotic Enoxaparin, heparin, desmopressin

Blood/blood components Immune globulins, albumin, FFP, KCentra

Anti-arrhythmic Verapamil, nitroglycerin, diltiazem

Anti-hypertensive Labetalol, hydralazine, furosemide, bumetanide

Vasopressors Norepinephrine, epinephrine, dopamine, dobutamine

Endocrine Insulin, Potassium iodide, Levothyroxine

Neonate Caffeine citrate, ibuprofen lysine, surfactant

Electrolytes Normal saline, 3% hypertonic saline, potassium chloride, calcium chloride, calcium gluconate, sodium bicarbonate, sterile water, sodium phosphate, potassium phosphate

TPN Amino Acids

Guidelines that call for critical, time-sensitive medications

Stroke Alteplase https://www.acc.org/latest-in-cardiology/ten-points-to-remember/2018/01/29/12/45/2018-guidelines-for-the-early-management-of-stroke

Myocardial infarction Tenecteplase (+ others already mentioned above) https://academic.oup.com/eurheartj/article/39/2/119/4095042#107689883

Sepsis Antibiotic therapy https://academic.oup.com/cid/article/65/9/1565/3966709

Others?

Exhibit G – Sample Criteria to Determine List of Critical Medications5

5 Work product of the Healthcare and Public Health Sector Coordinating Council

https://www.annemergmed.com/article/S0196-0644(17)30657-1/fulltext

https://www.annemergmed.com/article/S0196-0644(17)30657-1/fulltext

https://acls-algorithms.com/acls-drugs/

https://www.acc.org/latest-in-cardiology/ten-points-to-remember/2018/01/29/12/45/2018-guidelines-for-the-early-management-of-stroke



https://academic.oup.com/eurheartj/article/39/2/119/4095042#107689883

https://academic.oup.com/cid/article/65/9/1565/3966709


Premier welcomes the opportunity to work with FDA and additional stakeholders to continue to

refine the list of critical medications.

V. Conclusion

In closing, the Premier healthcare alliance appreciates the opportunity to submit comments on FDA-2018-

N-3272. Premier looks forward to working with the FDA to eliminate drug shortages and the downstream

impact to health systems and patient care.

If you have any questions regarding our comments or need more information, please contact Soumi Saha,

Senior Director of Advocacy, at [email protected] or 202-879-8005.

Sincerely,

Blair Childs

Senior Vice President, Public Affairs

Premier Inc.

mailto:[email protected]

and finding enduring solutions

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